Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the colon
• * Stage I disease
• * Distal border of tumor ≥ 12 cm from the anal verge
• Tumor completely resected within the past 90 days
• Must have undergone a preoperative or postoperative colonoscopy to the cecum (or small bowel anastomosis) within the past 90 days
• * All observed polyps must have been removed
• Patients with a history suggestive of hereditary non-polyposis colorectal cancer (HNPCC) must have a normal microsatellite instability status by immunohistochemistry or polymerase chain reaction
• * Patients with family history of colon cancer who have not been diagnosed with HNPCC are eligible
• No prior familial adenomatous polyposis
• No prior invasive cancer or carcinoma in situ of the colon or rectum
• No clinical or radiologic evidence of metastatic disease
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• Zubrod 0-1
• Life expectancy
• At least 10 years
• Hematopoietic
• Complete blood count normal
• Platelet count normal
• Hepatic
• Aspartate aminotransferase (AST) normal
• Bilirubin normal
• Alkaline phosphatase normal
• Renal
• Creatinine normal
• Cardiovascular
• No active ischemic heart disease
• No New York Heart Association class III or IV heart disease
• No myocardial infarction within the past 6 months
• No symptomatic arrhythmia
• No symptomatic peripheral vascular disease or carotid disease that would preclude study participation
• Pulmonary
• No aspirin-sensitive asthma
• Gastrointestinal
• No history of inflammatory bowel disease
• No history of upper gastrointestinal bleeding
• No history of duodenal or gastric ulcer
• Other
• No known hypersensitivity to any COX-2 inhibitor, NSAIDs, aspirin, or sulfonamides
• No non-colorectal malignancy within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer
• No other disease that would preclude study participation
• No psychiatric disorders, including history of clinical depression or addictive disorders, that would preclude giving informed consent or long-term compliance
• No rheumatologic or skeletal disorders requiring chronic NSAIDs or steroid therapy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• Not specified
• Endocrine therapy
• Not specified
• Radiotherapy
• Not specified
• Surgery
• See Disease Characteristics
• Other
• No other concurrent investigational agents for colon cancer
• No concurrent chronic use of other cyclo-oxygenase-2 (COX-2) inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), or salicylates (e.g., aspirin)
• * Chronic use is defined as use for more than an average of 3 days per month
• * Concurrent NSAIDs allowed for up to 10 consecutive days for temporary relief due to inflammatory syndromes, injury, or postoperative pain
• * Cardioprotective doses of aspirin (≤ 81 mg/day or 325 mg every other day) allowed
• No concurrent fluconazole or lithium